Senior Specialist Professional Education & Medical Affairs (Based in São Paulo)
Type
Full time
Location
Job reference
Req-37570
Posted for
1 day ago
Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.
How you´ll make an impact
Develops clinical education materials in connection with clinical investigations.
PRE-PROCEDURAL, INTRA-PROCEDURAL, POST-PROCEDURAL CASE SUPPORT
Represent the Clinical Affairs Research Team during complex clinical trial cases with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during clinical trial implants, including contingency planning to address unforeseen occurrences in support of assigned clinical investigations.
Provide education on all aspects of the device, device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants.
Document procedural case observations for insights in investigating post procedural events. Support enrollment discussions and assistance with issue escalation with Principal Investigator and research team
EDUCATION SUPPORT
Educate and train physicians, hospital personnel on technical matters related to investigational products and procedures through conducting and/or coordinating one-on-one ad hoc training sessions and in-service structured education programs.
Provide field training and guidance to new Clinical Specialists.
Throughout clinical investigations, provide physicians and medical staff with required follow-up support to ensure continuity of education and technical support related to all aspects of clinical research.
Develop and continuously improve training materials, training tools, and curriculum, based on clinical trial experience
RESEARCH SUPPORT
May develop material content and communications with investigational content for presentation at congresses and conventions and distribution to clinical sites.
May interface with investigation and clinical research staff to manage logistics associated with investigational meeting attendance, and protocol and device training.
Ensure device accountability by tracking the location of all clinical trial devices.
Manage inventory to include par levels, expiration dates, and initiate shipments and returns of investigational products according to regulatory and company guidelines.
May support leadership of team initiatives
Collaborate with product development teams to provide feedback and recommend solutions on device iterations and new device development.
Assist in Clinical Monitoring activities
What you will need
Bachelor's Degree in related field.
5 years of previous related medical device and/or clinical knowledge Required
Clinician knowledge in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) Preferred
Knowledge in interventional cardiology or cardiothoracic surgery Preferred
English and Spanish level required
What else will help you
Proven expertise in MS Office Suite and ability to operate general office machinery
Strong written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
Excellent problem-solving and critical thinking skills
Full knowledge and understanding of cardiovascular science
Full understanding of cardiovascular anatomy, pathology and physiology
Full understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Important Notices for Candidates
COVID Vaccination Requirement Notice
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
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